Purpose: To examine the effect of hydrogen (H2)-producing milk, which induces H2 production by intestinal microbiota, on the prevention of dry eye disease. Methods: A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted in humans. Of 118 candidates aged 20–60 years who were using visual display terminals daily, 54 subjects (mean age, 42.4 years) with mild-to-moderate dry eye symptoms, who were not dry eye patients based on the 2006 Japanese Diagnostic Criteria for Dry Eye, were included in the study. Subjects were assigned to the H2-producing milk group or the placebo group. They were instructed to ingest the assigned test beverage once per day for three consecutive weeks. Breath H2 concentration, fluorescein tear film breakup time (fTBUT), Schirmer's test, 8-OHdG concentration in tears, reported ocular symptoms using the dry eye-related QOL score questionnaire, and the visual analogue scale were assessed at weeks 0 and 3. Results: Change in fTBUT in the H2-producing milk group was significantly greater than that in the placebo group. A significant decline in fTBUT was observed in the placebo group (p = 0.04), but not the H2-producing group (p = 0.26). This phenomenon was strongly observed in females. We found a positive correlation between the change in fTBUT and net H2 production, and a negative correlation between the change in 8-OHdG concentration and net H2 production in young females. Conclusions: H2-producing milk appeared to retard the decline in tear stability and may prevent short fTBUT-type dry eye by decreasing oxidative stress in the lacrimal functional unit.
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